FDA Clears Updated Software for Faster Low-Field MRI Brain Scans
The ninth FDA clearance for the Swoop Portable MR Imaging system is for new software that enables significant scan time reduction for brain MRI scans.
The Swoop Portable MR Imaging system has garnered another FDA 510(k) clearance for new software that may facilitate more expedient diagnosis of neurological conditions.
The updated software reportedly offers significant reduction of scan times, facilitating use of the device’s ultra-low-field magnetic resonance imaging (MRI) capabilities in acute care settings, according to Hyperfine, the manufacturer of the Swoop Portable MR Imaging system.
A newly FDA-cleared software update for the Swoop Portable MR Imaging system facilitates significantly reduced scan times for low-field MRI brain imaging, according to Hyperfine, the manufacturer of the MRI system. (Image courtesy of Hyperfine.)
“Timely MR brain imaging is essential for clinicians making critical treatment decisions, particularly in acute neurological episodes like strokes. We have been an active site in the ACTION PMR study assessing the use of the Swoop® system in stroke diagnosis, and this latest software will help the Swoop® system more seamlessly integrate into stroke workflows,” noted Adnan Siddiqui, M.D., Ph.D., a professor and vice-chairman in the Department of Neurosurgery at the State University of New York at Buffalo’s Jacobs School of Medicine and Biomedical Sciences.
Hyperfine added that the reduced acquisition time for MRI sequences with the new software may help mitigate the impact of patient motion on brain scan quality.
Can Contrast-Enhanced Mammography be a Viable Screening Alternative to Breast MRI?
June 17th 2025While the addition of contrast-enhanced mammography (CEM) to digital breast tomosynthesis (DBT) led to over a 13 percent increase in false positive cases, researchers also noted over double the cancer yield per 1,000 women in comparison to DBT alone.
FDA Clears Enhanced MRI-Guided Laser Ablation System
June 5th 2025An alternative to an open neurosurgical approach, the Visualase V2 MRI-Guided Laser Ablation System reportedly utilizes laser interstitial thermal therapy (LITT) for targeted soft tissue ablation in patients with brain tumors and focal epilepsy.
Possible Real-Time Adaptive Approach to Breast MRI Suggests ‘New Era’ of AI-Directed MRI
June 3rd 2025Assessing the simulated use of AI-generated suspicion scores for determining whether one should continue with full MRI or shift to an abbreviated MRI, the authors of a new study noted comparable sensitivity, specificity, and positive predictive value for biopsies between the MRI approaches.
